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Axsome Therapeutics Receives FDA Fast Track Designation for AXS-02

 

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Axsome Therapeutics, Inc. received from the U.S. Food and Drug Administration (FDA) Fast Track designation for AXS-02 for the treatment of the pain of knee osteoarthritis (OA) associated with bone marrow lesions (BMLs). There is currently no product approved specifically for this indication.

AXS-02 is a potent osteoclast inhibitor being developed as an oral, targeted, non-opioid, potentially first-in-class therapeutic for chronic pain. AXS-02 is currently being evaluated in a Phase 3 trial, the COAST-1 study, for the treatment of knee OA associated with BMLs. This study is being conducted pursuant to an FDA Special Protocol Assessment.

“We are pleased that the FDA has granted Fast Track status for AXS-02 for the treatment of knee OA pain associated with bone marrow lesions,” said Herriot Tabuteau, M.D., Chief Executive Officer of Axsome. “This regulatory decision confirms that this novel indication represents an unmet medical need, and complements the FDA Special Protocol Assessment received for our recently initiated Phase 3 trial.”

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